Chemicals | Monthly bulletin | September 2024

Eurofins newsflash Chemical

Europe

New restrictions for PFHxA, its salts and related substances

On 20 September 2024, The European Commission published the Regulation (EU) 2024/2462 which amends the Annex XVII to Regulation (EC) No 1907/2006 as regards undecafluorohexanoic acid (PFHxA), its salts and PFHxA-related substances. For the purposes of this entry, PFHxA-related substances are substances that, based on their molecular structure, are considered to have the potential to degrade or be transformed to PFHxA.

The new restrictions are:

Annex XVII to Regulation (EC) No 1907/2006 – Entry 79
These substances shall not be placed on market, or used, in a concentration: ≥25ppb sum of PFHxA and its salts ≥1000 ppb sum of PFHxA-related substances
	Date	Affected products	Exception
1	10/10/2026	(a) textiles, leather, furs and hides in clothing and related accessories for the general public; (b) footwear for the general public; (c) paper and cardboard used as food contact materials within the scope of Regulation (EC) No 1935/2004; (d) mixtures for the general public; (e) cosmetic products of Regulation (EC) No 1223/2009.	(a) personal protective equipment to Regulation (EU) 2016/425; (b) devices of Regulation (EU) 2017/745; (c) devices of Regulation (EU) 2017/746; (d) textiles used as construction textiles; (e ) articles and mixtures which were placed on the market before 10 October 2026.
2	10/10/2027	In homogeneous material, in textiles, leather, furs and hides, Other than in clothing and related accessories referred to in paragraph 1, for the general public.	Articles which were placed on the market before 10 October 2027.
4	10/04/2026	Firefighting foams and firefighting foam concentrates for training, for testing and for public fire services.	(a) functional testing of the firefighting systems provided that all releases are contained; (b) where those services intervene at industrial fires at establishments covered by Directive 2012/18/EU and they use the foams and the equipment for that purpose only. (c ) Substances having a perfluoroalkyl group C6F13- directly attached to a sulphur atom that are prohibited in Annex I to Regulation (EU) 2019/1021.
5	10/10/2029	In firefighting foams and firefighting foam concentrates for civil aviation (including in civilian airports)	Substances having a perfluoroalkyl group C6F13- directly attached to a sulphur atom that are prohibited in Annex I to Regulation (EU) 2019/1021.

This Regulation shall enter into force on 10 October 2024.

Six chemicals identified as Substances of Very High Concern

On the 30^th of August 2024, The European Chemical Agency (ECHA) published a list of proposed substances which may be identified as Substances of Very High Concern (SVHC) and which will be added to the Candidate list for eventual inclusion in the Authorisation list.

The six substances are:

Name	EC Number	CAS Number	Reason for proposing
6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid	701-118-1	2156592-54-8	Toxic for reproduction (Article 57c)
O,O,O-triphenyl phosphorothioate	209-909-9	597-82-0	PBT (Article 57d)
Octamethyltrisiloxane	203-497-4	107-51-7	vPvB (Article 57e)
erfluamine	206-420-2	338-83-0	vPvB (Article 57e)
Reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives	421-820-9	192268-65-8	PBT (Article 57d)
ris(4-nonylphenyl, branched and linear) phosphite	-	-	Endocrine disrupting properties (Article 57(f) – environment)

Status of European initiatives related to chemicals

Below is a table that summarises the status of these initiatives:

Published initiative	Status
Persistent organic pollutants - methoxychlor This draft regulation amends Annex I to the Regulation (EU) 2019/1021 on persistent organic pollutants (POP), with a decision to add methoxychlor to the Convention. This initiative amends Annex I to the Regulation to include methoxychlor as a substance, subject to certain restrictions.	The Commission’s adoption was on the 22^nd of July 2024.
Persistent organic pollutants - UV-328 This draft regulation amends Annex I to the Regulation (EU) 2019/1021 on persistent organic pollutants (POP), with a decision to add UV-328 to the Convention. This initiative amends Annex I to the Regulation to include UV-328 as a substance subject to certain restrictions.	The European Commission is working on the preparation of the Draft Act.
Marketing and use of explosives precursors – updated rules This initiative will revise those rules by: addressing the shortcomings identified by the evaluation possibly broadening the scope to cover high-risk chemicals which can be misused to stage attacks.	A public consultation is planned for fourth quarter 2024.

Interesting resources on the REACH Regulation on ECHA’s website

Interesting resources on the CLP Regulation on ECHA’s website

Regulatory proposals notified to the WTO

The table below summarises the most recent notifications made to the World Trade Organization (WTO) (non-exhaustive):

Notification number

Entity

Title

G/TBT/N/EU/1079

European Commission

Draft Commission Regulation (EU) .../...of XXX amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards N, N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP).

It proposes a restriction for placing N, N-dimethylacetamide (DMAC) and 1-ethylpyrrolidin-2-one (NEP) with concentrations of higher than 0.3% on the market unless the registration dossiers and the safety data sheet are updated with the new DNEL values, and manufacturers and downstream users ensure the protection of workers by keeping their exposure below those values.

G/TBT/N/FRA/234

European Commission

Draft Decree amending Decree No. 2023-1224 of 20 December 2023 on the inclusion of a warning label on individual packaging units for products containing only nitrous oxide.

Switzerland

Alignment with European chemical requirements

On the 6^th of August 2024, the Swiss Federal Office of Public Health updated the 813.11 Ordinance on Protection against Dangerous Substances and Preparations (Chemicals Ordinance, OChim) with the ordinance RO 2024 404, which modifies the following annexes:

Annex 2: Technical requirements for CLP and Test methods for properties of substances and preparations.
Annex 3: Candidate List of SVHC. The list now contains 240 substances.

This way, the Swiss legislation related to chemicals aligns the national requirements with the European Requirements (referring to Regulation (EC) No. 1272/2008, as last amended by Regulation (EU) 2024/197).

It entered into force on the 1^st of September 2024.

For more information, consult the official publication on the Swiss Confederation website here (French, German, and Italy version).

New Hampshire Regulates PFAS in Various Products

On the 2^nd of August 2024, the State of New Hampshire approved HB 1649 to regulate perfluoroalkyl and polyfluoroalkyl substances (PFAS) in various consumer products.

PFAS is defined as any chemical substance or mixture containing a chemical substance that structurally contains at least one of the following three sub-structures:

R-(CF₂)-CF(R′)R″, where both the CF₂ and CF moieties are saturated carbons.
R-CF₂OCF₂-R′, where R and R′ can either be F, O, or saturated carbons.
CF₃C(CF₃)R′R″, where R′ and R″ can either be F or saturated carbons.

Refer to Table 1 below for details of HB 1649.

Table 1:

Product Category	Requirement	Effective Date
Carpets or rugs	Prohibited if PFAS is intentionally added	01/01/2027
Cosmetics
Textile treatments
Feminine hygiene products
Food packaging and containers
Juvenile products
Upholstered furniture
Textile furnishings

Standards updates

See below a table summarising some recent ASTM standards updates:

Reference	Title
ASTM D5253-24	Standard Terminology Relating to Floor Coverings and Textile Upholstered Furniture
ASTM F2640-18(2024)	Standard Consumer Safety Specification for Booster Seats
ASTM F3317-20(2024)	Standard Consumer Safety Specification for Infant Floor Seats
ASTM F3343-20(2024)	Standard Consumer Safety Specification for Infant Bathers

Canada

Canada Issues Notice of PFAS Reporting Requirement

On the 27^th of July 2024, Canada’s Department of the Environment issued a notice in the Canada Gazette requiring businesses that manufactured or imported listed perfluoroalkyl and polyfluoroalkyl substances (PFAS) or PFAS containing articles in the 2023 calendar year to submit reports by the 29^th of January 2025. Reports should be submitted to the Minister of the Environment using the online reporting system available through Environment and Climate Change Canada’s Single Window.

The reporting obligations apply to anyone who, during the 2023 calendar year:

manufactured a total quantity greater than 1,000 g of any substance listed in Schedule 1;
imported a total quantity greater than 10 g of a substance listed in Part 1 of Schedule 1, or a total quantity greater than 100 kg of a substance listed in Part 2 or Part 3 of Schedule 1, whether the substance was
1. alone;
2. at a concentration equal to or above 1 ppm in a mixture, or in a product;
3. at a concentration equal to or above 1 ppm in a manufactured item:
  1. that is intended to be used by or for children under the age of 14 years,
  2. that is intended to come into contact with the mucosa of an individual,
  3. that is intended to be used in a manner such that the substance may be inhaled, or come into dermal or oral contact with an individual,
  4. that is cookware, or a cooking or serving utensil that is intended to come into direct contact with heated food or beverage,
  5. that is food packaging material, including single-serve/disposable bowls, plates, cups, other serving-ware, as well as food cans and lid liners, that are intended to or may come into direct contact with food or beverage,
  6. that is a reusable food or beverage container,
  7. that is food processing equipment, including conveyor belts, trays, vats, nozzles, moulds, and cutters that come into contact with food or beverage prior to packaging and distribution,
  8. that is clothing or footwear, including life jackets, personal flotation devices, and other safety apparel,
  9. that is bedding, sleeping bags, or towels,
  10. that is furniture, mattresses, cushions or pillows intended to be used by an individual, where the substance is contained in foam or leather or in a textile fibre, yarn or fabric,
  11. that is carpet, vinyl or laminate flooring, or foam underlay for flooring, intended to be used by an individual,
  12. such that the substance is intended to be released from the manufactured item;
imported a total quantity greater than 100 kg of any substance listed in Schedule 1 at a concentration equal to or above 1 ppm in a manufactured item other than those listed in paragraph 2(2)(c); or
used a total quantity greater than 10 g of any substance listed in Schedule 1, whether the substance was alone or at a concentration equal to or above 1 ppm in a mixture or in a product, in the manufacture of a mixture, a product or a manufactured item.

International

Regulatory proposals related to chemicals

The table below summarises the most recent draft related to chemical legislations (non-exhaustive):

Notification number

Entity

Title

G/TBT/N/BRA/1565

National Institute of Metrology, Quality and Technology (INMETRO)

Brazil

Draft resolution 1275, 27 August 2024

This draft resolution contains provisions on criteria for the regularisation of cleaning products and the like and on the biodegradability of anionic surfactants. It is a proposal to review the Mercosur Technical Regulation for Cleaning and Related Products, GMC Resolution No. 47/07.

Ministerial Resolution No. 00214-2024-MINAM

Ministry of the Environment (Minam)

Peru

Provides for the publication of the draft Regulations for Legislative Decree No. 1570, Legislative Decree approving the Law on Comprehensive Management of Chemical Substances and its annex; as well as the draft Supreme Decree approving it and the Statement of Reasons.

Sustainability, circular economy and environment

Miscellaneous technical publications relating to environmental, plastics, packaging and waste

The table below summarises the most recent publications regarding sustainability, the Circular economy, and the environment (non-exhaustive):

Entity	Date	Publication
The Minister for Ecological Transition and Territorial Cohesion (France)	06/07/2024	Order of July 3, 2024 amending the specifications of eco-organisations and coordinating organisations of the extended producer responsibility sector for construction products and materials in the building sector annexed to the ministerial order of June 10, 2022.
The Minister for Ecological Transition and Territorial Cohesion (France)	07/07/2024	Decree No. 2024-742 of July 6, 2024 containing various provisions for implementing the Green Industry Act and simplification in environmental matters.
European Commission	10/07/2024	Directive (EU) 2024/1799 of the European Parliament and of the Council of 13 June 2024 on common rules promoting the repair of goods and amending Regulation (EU) 2017/2394 and Directives (EU) 2019/771 and (EU) 2020/1828
European Commission	24/07/2024	Packaging and packaging waste – Amendments adopted by the European Parliament on the 22^nd of November 2023 on the proposal for a regulation of the European Parliament and of the Council on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (COM(2022)0677 – C9-0400/2022 – 2022/0396(COD).
European Commission	29/07/2024	Regulation (EU) 2024/1991 of the European Parliament and of the Council of 24 June 2024 on nature restoration and amending Regulation (EU) 2022/869
European Commission	30/07/2024	European Environment Agency – 2017-2021 performance evaluation This initiative will assess how the European Environment Agency and its European Environment Information and Observation Network has performed in 2017-2021, and how relevant its strengthened mandate is in the recent EU policy context.
European Commission	31/07/2024	Environmental protection – LIFE Programme 2014-2020 (evaluation) This evaluation will assess: whether the programme is working as intended the extent to which the programme’s objectives have been realised.
European Commission	01/08/2024	Commission Implementing Decision (EU) 2024/2053 of 30 July 2024 allocating rights to produce hydrofluorocarbons pursuant to Article 14 of Regulation (EU) 2024/573 of the European Parliament and of the Council on fluorinated greenhouse gases to producers that produced such substances in 2022 (notified under document C(2024) 5212)
European Chemical Agency (ECHA)	05/08/2024	The revised Industrial Emissions Directive entered into force on the 4^th of August 2024. ECHA will join the exchange of information to draw up, review and update Best Available Techniques (BAT) reference documents (BREFs). This is known as the Sevilla process and is used for setting permit conditions for industry.
European Commission	07/08/2024	Commission Implementing Regulation (EU) 2024/2140 of 6 August 2024 amending and correcting Implementing Regulation (EU) 2021/1378 as regards the recognition of certain control bodies in accordance with Article 46 of Regulation (EU) 2018/848 of the European Parliament and of the Council as competent to carry out controls and issue organic certificates in third countries for the purpose of imports of organic products into the Union.
European Commission	07/08/2024	Commission Notice – Technical guidelines regarding methods of analysis for monitoring of per- and polyfluoroalkyl substances (PFAS) in water intended for human consumption
European Parliament	20/08/2024	Eco-design requirements for sustainable products European Parliament published an article about the Eco-design legislation which explain all the process and aims until nowadays.
European Commission	03/09/2024	Commission Implementing Regulation (EU) 2024/2174 of 2 September 2024 laying down rules for the application of Regulation (EU) 2024/573 of the European Parliament and of the Council as regards the format of the labels for certain products and equipment containing fluorinated greenhouse gases and repealing Commission Implementing Regulation (EU) 2015/2068
European Commission	09/09/2024	Endangered animal and plant species – suspension of imports from non-EU countries (update) This initiative updates the list species of wild plants and animals from non-EU countries. The feedback period about the draft act is opened until the 7^th of October 2024.
European Commission	16/09/2024	2024/0518/DK (Denmark) Order on certain requirements concerning packaging, extended producer responsibility for packaging, and other waste collected with packaging waste
European Commission	20/09/2024	Commission Implementing Regulation (EU) 2024/2473 of 19 September 2024 laying down rules for the application of Regulation (EU) 2024/573 of the European Parliament and of the Council as regards the registration in the F-gas Portal and repealing Commission Implementing Regulation (EU) 2019/661
European Commission	20/09/2024	Calculation and verification methodology of rates for recycling efficiency and recovery of materials of waste batteries The objective of this European initiative is to support the circular economy in the battery sector and ensure high quality of recovery of materials, especially of critical and strategic raw materials. The calculation and verification methodology is important to ensure a level playing field between recyclers and provide legal certainty on requirements within the EU.